DMPK and PKPD Metabolite Profiling and ID
Bioanalytical Chemistry ADME-Assisted Drug Screening
ADME-Assisted Lead Optimization Drugability Evaluation
Dr. Bu has had 30 years of scientific and managerial experience in drug discovery and development in major pharmaceutical and CRO companies. At Covance, Dr. Bu deeply learned how a top CRO company would satisfy clients with premier services. At Pfizer, Dr. Bu participated in the discovery and development of a number of dug candidates and two anticancer drugs, Sunitinib (2006) and Axitinib (2011), and won two prestigious awards, the James R. Gillette Best Drug Metabolism Paper Award of 2005 (ASPET) and the W. E. Upjohn Award in Innovation of 2006 (Pfizer). In addition, Dr. Bu has published over 60 original papers and invited reviews in ADME and bioanalytical sciences.
In 2008, Dr. Bu resigned from Pfizer and immediately returned to Suzhou, China, to build up 3D BioOptima (圣苏圣苏新药开发有限公司), providing specialized services in DMPK, PKPD, and bioanalytical sciences. With his extensive R&D experience, over the past ten years, Dr. Bu has been providing high value-added consulting activities for current and potential clients free of charge.
25+years of drug developmental experience in Synsorb Biotech, Biomira, and Merck Sorono.
7 years of medical practices in Bethune Medical University and 18 years of R&D experience in Pfizer, HD Biosciences, and Viva Biotech.
LC-MS/MS Lab Operation
20+years of working experience in multinational CRO companies, including Covance, Charles River, and PPD.
30-yearscientific/managerial experience in drugR&Dat Sanofi,J&J, Alza, Exelixis,and QR Pharma.
30-year scientific/managerial experience in drug R&D at MDS Pharma, Intertek, XBL, and ELIM.
20-year working experience at Univ. Victoria, UBC, Cornell Univ, MD Anderson Cancer Center, and Revance Therapeutics.
Quality Management System
FDA/CFDA Regulatory Affairs
R&D Process Quality Control
12 years of working experience in quality assurance and quality control.
DMPK Study and Management
GLP Regulatory Affairs
R&D Process Management
12 years of working experience in DMPK study and project management.
In-Vitro Activity Screening
Animal Disease Models
Animal PKPD Models
12 years of working experience in pharmacology and DMPK studies.
Bioanalysis Using LC-MS/MS
GLP/GCP BA Regulations
LC-MS/MS Lab Operation
9 years of working experience in bioanalysis and BA lab operation.
6+ years of working experience in bioanalysis and BA lab operation.
Process Planning & Modeling
Digital Process Management
Digital Performance Management
3 years of working experience in process management in the pharma/CRO environment.